Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DJO, LLC. VECTRA GENYSIS; STIMULATOR, MUSCLE, POWERED
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DJO, LLC. VECTRA GENYSIS; STIMULATOR, MUSCLE, POWERED Back to Search Results
Model Number 27335
Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)
Patient Problems Pain (1994); Injury (2348); Burn, Thermal (2530); Superficial (First Degree) Burn (2685)
Event Date 09/28/2016
Event Type  malfunction  
Event Description
Patient was placed on electrical stimulation for 10 min.Afterwards, the patient complained of pain in his back area.The patient was noted to have 4 skin lesions, 2 cervical area and 2 lumbar area.It appears the stim unit malfunctioned causing the patient to receive more stimulation than intended.The patient has 2 small 1st degree burns just below neck, each approx 1 cm in diameter, no drainage, no red streaking, no blistering.The patient has another 2 small 1st degree burns to the lower back just above the belt line, each one is approximately 1 cm in diameter, no redness, no drainage, no blistering.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
VECTRA GENYSIS
Type of Device
STIMULATOR, MUSCLE, POWERED
Manufacturer (Section D)
DJO, LLC.
1430 decision st.
vista CA 92081
MDR Report Key6120699
MDR Text Key60678443
Report Number6120699
Device Sequence Number1
Product Code IPF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 10/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2016
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number27335
Device Catalogue Number27335
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/07/2016
Event Location Outpatient Treatment Facility
Date Report to Manufacturer10/07/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age54 YR
Patient Weight92
-
-